Data / Medical devices / South Korea / Sentech Korea Corp.
Sentech Korea Corp.: FDA-registered device maker in PAJU-SI Gyeonggi, South Korea, 3 510(k) clearances
Sentech Korea Corp. is registered with the FDA (registration 3003383868) in PAJU-SI Gyeonggi, South Korea. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 30, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003383868
- Address
- 21-6, Jimok-ro 75beon-gil, PAJU-SI Gyeonggi, South Korea, 10880
- Owner or operator
- Sentech Korea Corp (9066277)
- Roles
- Manufacturer
- First device listed
- November 30, 2004
- Registered through
- 2026
- Brand names listed
- ACE Easy, ACE II Basic, ACE III Basic, ACE Neo, ACE Soild, ACE Trusty, ACE X, ACE XS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | 1 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 30, 2006 | K061922 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 | DJZ | Substantially Equivalent | Sentech Korea Corp. | accessdata.fda.gov |
| May 11, 2006 | K060343 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 | DJZ | Substantially Equivalent | Sentech Korea Corp. | accessdata.fda.gov |
| January 20, 2006 | K053332 | BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 | DJZ | Substantially Equivalent | Sentech Korea Corp. | accessdata.fda.gov |
Compare with other makers
Updated October 30, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.